FDAnews
www.fdanews.com/articles/75829-fda-approves-caraco-s-clozapine

FDA APPROVES CARACO'S CLOZAPINE

August 26, 2005

The FDA has approved Caraco Pharmaceutical Laboratories' abbreviated new drug application for clozapine in 50-mg tablets. Caraco already has FDA approval to manufacture clozapine in 25- and 100-mg dosages, the company said. Caraco's product is the generic equivalent of Novartis' antipsychotic drug Clozaril, which had 2004 sales of $308 million.